Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation

Neoplasms Clinical Trial

— COLT  

Official title:

Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation: a Prospective Parallel Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03803436
• Other study ID #: INT 108/18
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2, 2019
• Est. completion date: January 2024

Study information

• Verified date: March 2023
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: Vincenzo Mazzaferro, MD, PhD
• Phone: +39 02 23902760
• Email: segreteria.mazzaferro[@]istitutotumori.mi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The COLT trial is an investigator-driven, multicenter, non-randomized, open-label, controlled, prospective, parallel trial, aimed at assessing the efficacy (in terms of overall survival: OS) of liver transplantation (LT) in liver-only CRC metastases, compared with a matched cohort of patients bearing the same tumor characteristics, collected during the same time period and included in a phase III Italian RCT on triplet chemotherapy+antiEGFR

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed non-mucinous colon adenocarcinoma.

• Primary tumor as pT1-3, pN0 or pN1 (metastases in < 4 regional lymph nodes), confirmed R0 resection.

• RAS and BRAF wild-type & MSS molecular status as per local testing.

• Liver metastases not eligible for curative liver resection

• Objective response according to RECIST 1.1 to first-line treatment, with sustained response for at least 4 months, OR disease control (CR+PR+SD) during second-line treatment for at least 4 months.

• A maximum of two prior chemotherapy treatment lines.

• Performance status, ECOG 0.

• Satisfactory blood tests Hb >10g/dl, neutrophils >1.0 (after any G-CSF), TRC >75, Bilirubin<2 x upper normal level, AST, ALT<5 x upper normal level, creatinine <1.25 x upper normal level.

• CEA<50 ng/ml

Exclusion Criteria:

• Hereditary CRC syndromes including FAP and Lynch syndrome.

• Prior extra hepatic metastatic disease or primary tumor local relapse.

• Extra-peritoneal cancers (rectum).

• Other malignancies in the previous 5 years

• Active intra-venous or alcohol abusers

• HIV infection

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms
• Liver Metastases
• Liver Neoplasm
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Procedure:
• Liver transplant
Liver transplant from cadaveric donors

Drug:
• Chemotherapy
mFOLFOX
• Chemotherapy
Panitumumab

Locations

Country	Name	City	State
Italy	SOD Clinica di Chirurgia Epatobiliare, Pancreatica e dei Trapianti e SC di Oncologia Medica, Ospedali Riuniti di Ancona	Ancona
Italy	ASST Papa Giovanni XXIII	Bergamo
Italy	Chirurgia EBP e dei Trapianti di Fegato e SC di Oncologia Medica, Ospedale Policlinico San Martino	Genova
Italy	Fondazione IRCCS Istituto NAzionale Tumori di Milano	Milan
Italy	Azienda Ospedaliera Ospedale Niguarda Ca' Granda	Milano
Italy	Ospedale Maggiore di Milano Policlinico	Milano
Italy	Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)	Palermo
Italy	GONO Group (Gruppo Oncologico Nord Ovest) TRIPLETE Trial Coordination	Pisa
Italy	Fondazione Policlinico Universitario A.Gemelli IRCCS	Roma
Italy	Ospedale Universitario Molinette S. Giovanni Battista di Torino	Torino
Italy	Centro Trapianti di Fegato e SC di Oncologia Medica, A.S.U. Integrata di Udine	Udine
Italy	Centro Trapianti di Fegato e SC di Oncologia Medica, A.O.U. Integrata di Verona	Verona

Sponsors (3)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano	Gruppo Oncologico del Nord-Ovest, Istituto Di Ricerche Farmacologiche Mario Negri

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Time from enrolement to either death or censoring	5 years
Secondary	Progression Free Survival	Time from enrolement to either progression or censoring	5 years
Secondary	Complications rate	Complications according to Dindo Clavien Classification	90 days after liver transplant